MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PULSED FIELD ABLATION SYSTEM; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/27/2024

Event Type  Injury  

Event Description

During fluoro-guided transeptal puncture performed with a non-biosense webster needle, nor sheath, the ascending aorta was punctured.After a waiting time of thirty (30) minutes, the electrocardiogram (ecg) and transesophageal echocardiography did not reveal any complication to the patient and the procedure was resumed.During the same procedure, during ablation of the posterior wall with pfa (boston scientific), the patient lost intrinsic electrical conduction.Sinus rhythm was lost but a junctional spontaneous rhythm recovered towards the end of the procedure.At the time, the physiological electrical conduction was lost.There were no biosense webster catheters present in the patient¿s body.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSED FIELD ABLATION SYSTEM
• Type of Device: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18922671
• MDR Text Key: 338110821
• Report Number: MW5152936
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2024
• Patient Sequence Number: 1